Regulations

Directive 2011/62/EU

Until recently, laws on the online trade in medicinal products in the EU were extremely diverse, which has created confusion among customers and has caused severe difficulties for investigations and prosecutions. Currently EU Member States are changing their legal provisions according to the (EU) Directive 2011/62 in an attempt to harmonise the differences among Member States regarding the regulation of sales at a distance of medicinal products.

For example, some Member States that did not allow their sales at a distance, have now to allow at least the online sales of OTCs. Furthermore, every State must regulate in detail every aspect of the online sales of medicinal products in the country. Nevertheless, even after the transposition of the Directive, some differences among Member States regulation will persist (e.g. the online trade of prescription-only medicines will be legal in a few EU countries only).

According to the Directive 2011/62/EU, each Member State shall set up a website providing information on the national legislation applicable to the sale at a distance to the public of medicinal products, including information on the differences between Member States regarding classification of medicinal products and the conditions for their supply.

The Medicrime Convention

The falsification of medicinal products until recently escaped the attention of international criminal law. In 2010, The Council of Europe adopted the “Convention on the counterfeiting of medical products and similar crimes involving threats to public health” (Medicrime Convention) to criminalize acts related to medicine falsification. The Medicrime Convention (not yet into force) has been the first binding international treaty in this field.

By aiming at harmonizing legislations, it brings clarity to legal definitions of the actions criminalized (namely falsification, but also manufacture and supply) and introduces common minimum standards on substantive and procedural criminal law, thus improving cooperation among countries. It also offers a framework in which to coordinate the exchange of information and case management by creating a single point of contact (SPOC) in every country. The Medicrime Convention sees the use of mass distribution means (like the Internet) to traffic falsified medicines as an aggravating factor.